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Supporting Care Through Compassionate Use

Sumitomo Pharma America, Inc. is committed to the development of therapies to benefit patients living with serious diseases or conditions who have not had success with existing, available therapies. Our aim is to provide these therapies to the broadest number of patients possible, through performance of clinical research with the goal of obtaining regulatory approval.

While clinical trials remain the preferred and most effective pathway for evaluating safety and efficacy, SMPA recognizes that some patients may be ineligible for trials and lack suitable treatment alternatives. In such limited circumstances, and particularly for eligible patients in the United States with serious or life threatening cancers, SMPA may consider providing access to its investigational products outside of clinical trials through its Expanded Access Program (also known as compassionate use), when no comparable or satisfactory options are available.

Program Availability

Requests for expanded access must comply with US Food and Drug Administration (FDA) regulations and applicable Institutional Review Board (IRB) requirements. Requests from outside the United States cannot be accommodated at this time.

Enzomenib (DSP-5336)

View Expanded Access Portal

Requesting Expanded Access

Requests for access to investigational products must be made by a qualified and licensed physician. The physician requesting Expanded Access must provide specific case information, including:

  • Copy of the physician's curriculum vitae (CV), signed and dated, and a copy of the physician's current medical license (US only)
  • Pertinent patient history
  • Scientific rationale
  • Confirmation that the patient has exhausted reasonable approved therapy options, or the patient is no longer responsive to, or able to tolerate these therapies
  • Confirmation that there are no reasonable and viable alternative therapy options
  • A statement as to whether the physician intends to seek cost-recovery from an insurer, patient, or other third-party and the process for complying with applicable regulatory and insurer requirements
A document and a shield with a checkmark on it icon

Submit Request

If the patient and requesting physician meet eligibility requirements, the request for expanded access can be made below.

Request Expanded Access

Email for Support or More Information:

info@us.sumitomo-pharma.com

Call Sumitomo Medical Information:

+ 1 (800) 739-0565

Hours: Monday - Friday, 8 AM - 8 PM ET

Policy Requirements and Evaluation of Request

Each request will be evaluated by Sumitomo Pharma America, Inc. in accordance with this Policy and will be required to meet all criteria.

Browse Clinical Trials

Explore our investigational pipeline, including upcoming and actively recruiting clinical trials, or access the full clinical trial registry.

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